Package leaflet: Information for the user

Bevimlar, 15 mg, film-coated tablets
Bevimlar, 20 mg, film-coated tablets
Rivaroxaban
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Bevimlar is and what it is used for
What you need to know before you take Bevimlar
How to take Bevimlar
Possible side effects
How to store Bevimlar
Contents of the pack and other information

1. What Bevimlar is and what it is used for

Bevimlar contains the active substance rivaroxaban.
Bevimlar is used in adults to:

prevent blood clots forming in the brain (stroke) and in other blood vessels in the body when the patient has an irregular heartbeat known as non-valvular atrial fibrillation
treat blood clots in the deep veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent the recurrence of blood clots in the veins and/or lungs.

Bevimlar is used in children and adolescents under 18 years of age and weighing 30 kg or more, to:

treat blood clots and to prevent recurrence of blood clots in the veins or in the blood vessels of the lungs, after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

Bevimlar belongs to a group of medicines called anticoagulants. It works by blocking a blood clotting factor (Factor Xa), thereby reducing the tendency for blood clots to form.

2. Important information before using Bevimlar

When not to use Bevimlar

if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
if the patient is experiencing excessive bleeding
if the patient has a disease or condition of an organ that leads to an increased risk of serious bleeding (e.g. stomach ulcer, trauma or bleeding into the brain, recent surgery on the brain or eyes)
if the patient is taking other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain the patency of an intravenous or arterial catheter
if the patient has a liver disease that leads to an increased risk of bleeding
if the patient is pregnant or breastfeeding.

Do not use Bevimlar, and inform your doctor if the patient suspects that any of the above circumstances apply.
Warnings and precautions
Talk to your doctor or pharmacist before taking Bevimlar.
When to exercise particular caution when taking Bevimlar

if the patient has an increased risk of bleeding, such as: severe kidney disease in adults and moderate to severe kidney disease in children and adolescents, as kidney function may affect the amount of medicine acting in the patient's body; when taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin) during a switch in anticoagulant therapy or when heparin is administered to maintain the patency of an intravenous or arterial catheter (see section "Bevimlar with other medicines"); blood clotting disorders; very high blood pressure that does not decrease despite medication; diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or esophagitis (throat and esophagus), e.g. due to gastroesophageal reflux disease (acid reflux into the esophagus) or tumors located in the stomach, intestines, genital or urinary system; vascular disease of the back of the eyeball (retinopathy); lung disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
in patients with prosthetic heart valves,
if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing an increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is necessary,
if the patient has been diagnosed with abnormal blood pressure or if surgery or another treatment to remove a blood clot from the lungs is planned.

If the patient suspects that any of the above conditions apply, inform the doctor
before using Bevimlar. The doctor will decide whether to use this medicine and whether the patient
should be placed under particularly close observation.
If the patient needs to undergo surgery:

strictly follow the doctor's instructions regarding the timing of taking Bevimlar before or after surgery
if catheterization or spinal puncture (e.g. for epidural or spinal anesthesia or pain relief) is planned during surgery:
it is very important to take Bevimlar at precisely the times specified by the doctor before and after the puncture or removal of the catheter
inform the doctor immediately if, after anesthesia ends, symptoms such as numbness or weakness in the legs, or disturbances in bowel or bladder function occur, as immediate treatment will be necessary in such cases.

Children and adolescents
Bevimlar tablets are not recommended for children weighing less than 30 kg.
There is insufficient data on the use of Bevimlar in children and adolescents for the indications approved for adults.
Bevimlar with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

If the patient is taking:
some medicines used to treat fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin
oral ketoconazole (used in the treatment of Cushing's syndrome, in which the body produces too much cortisol)
some antibiotics used to treat bacterial infections (e.g. clarithromycin, erythromycin)
some antiviral medicines used to treat HIV infection or AIDS (e.g. ritonavir)
other medicines used to reduce blood clotting (e.g. enoxaparin, clopidogrel, or vitamin K antagonists such as warfarin or acenocoumarol)
anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
dronedarone, a medicine used to treat heart rhythm disorders
some medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs))

If the patient suspects that any of the above conditions apply, inform the doctor
before using Bevimlar, as the effect of Bevimlar may be enhanced. The doctor will decide whether to use this medicine and whether the patient should be placed under particularly close observation.
If the doctor considers that the patient has an increased risk of developing stomach or intestinal ulcers, they may prescribe treatment to prevent peptic ulcer disease.

If the patient is taking:
some medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital)
St. John's wort (Hypericum perforatum), a herbal remedy used for depression
rifampicin, which belongs to the group of antibiotics

If the patient suspects that any of the above conditions apply, inform the doctor
before using Bevimlar, as the effect of Bevimlar may be reduced. The doctor will decide whether to use Bevimlar and whether the patient should be placed under particularly close observation.
Pregnancy and breastfeeding
Do not use Bevimlar if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, an effective method of contraception should be used during treatment with Bevimlar. If the patient becomes pregnant while taking this medicine, inform the doctor immediately, who will decide on further management.
Driving and operating machinery
Bevimlar may cause dizziness (common side effects) and fainting (uncommon side effects) (see section 4, "Possible side effects"). Patients experiencing these side effects should not drive, ride a bicycle, or operate tools or machinery.
Bevimlar contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking the medicine.
Bevimlar contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to take Bevimlar

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Bevimlar should be taken with food.
The tablet(s) should be swallowed whole, preferably with water.
If a patient has difficulty swallowing the whole tablet, they should speak to their doctor about alternative
ways of taking Bevimlar. The tablet may be crushed and mixed with water or soft food such as apple
purée immediately before administration. A meal should be taken immediately after this mixture. If
necessary, a doctor may administer crushed Bevimlar tablets through a gastric tube.

How many tablets to take

Adults
o For prevention of blood clots in the brain (stroke) and other blood vessels in the body:
The recommended dose is one 20 mg Bevimlar tablet once daily. If the patient has impaired kidney function, the dose may be reduced to one 15 mg Bevimlar tablet once daily.
o If the patient requires a procedure to open blood vessels in the heart (called percutaneous coronary intervention – PCI with stent placement), there is limited evidence supporting dose reduction to one 15 mg Bevimlar tablet once daily (or one 10 mg Bevimlar tablet once daily in case of kidney impairment), in combination with an antiplatelet medicine such as clopidogrel.
o For treatment of blood clots in the legs, blood clots in the blood vessels of the lungs, and prevention of recurrence of blood clots:
The recommended dose is one 15 mg Bevimlar tablet twice daily for the first 3 weeks.
After 3 weeks of treatment, the recommended dose is one 20 mg Bevimlar tablet once daily.
After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment with either one 10 mg tablet once daily or one 20 mg tablet once daily.
If the patient has impaired kidney function and is taking one 20 mg Bevimlar tablet once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg Bevimlar tablet once daily, if the risk of bleeding is greater than the risk of further blood clots.
Children and adolescents
The dose of Bevimlar depends on body weight and will be calculated by the doctor.
o Recommended dose for children and adolescents with a body weight from 30 kg to below 50 kg is one 15 mg Bevimlar tablet once daily.
o Recommended dose for children and adolescents with a body weight of 50 kg or more is one 20 mg Bevimlar tablet once daily.
Each dose of Bevimlar should be taken with a meal, accompanied by a drink (e.g. water or juice). Tablets should be taken daily at approximately the same time. Consider setting an alarm as a reminder.
For parents or caregivers: monitor the child to ensure they have taken the full dose.

The dose of Bevimlar depends on body weight; therefore, it is important to attend scheduled doctor’s
appointments, as dose adjustments may be necessary due to changes in weight.
Never adjust the dose on your own. If needed, the doctor will adjust the dose.
Do not split the tablet to achieve a partial dose. If a lower dose is required, another formulation of
rivaroxaban should be used, for example, granules for oral suspension.
For children and adolescents who are unable to swallow whole tablets, rivaroxaban should be used in
another formulation, such as granules for oral suspension.
If the oral suspension is not available, the Bevimlar tablet may be crushed and mixed with water or
apple purée immediately before administration. A meal should be taken after this mixture. If necessary,
the doctor may also administer the crushed tablet via a gastric tube.

If a dose is vomited or expelled

Within 30 minutes of taking Bevimlar, take a new dose.
More than 30 minutes after taking Bevimlar, do not take a new dose. In this case, take the next dose at the usual time.

Contact your doctor if there are repeated instances of vomiting or expulsion of the dose after taking Bevimlar.

When to take Bevimlar
Take the tablet(s) every day until your doctor decides to stop treatment.
It is best to take the tablet(s) at the same time each day, as this makes it easier to remember.
Your doctor will decide how long treatment should continue.
For prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If heart rhythm needs to be restored to normal rhythm by a procedure called cardioversion, Bevimlar should be taken at the time prescribed by the doctor.

If a dose of Bevimlar is missed

Adults, children and adolescents: If the patient takes one 20 mg tablet or one 15 mg tablet once daily and a dose is missed, take the tablet as soon as possible. Do not take more than one tablet in one day to make up for the missed dose. Take the next tablet the following day, then continue taking one tablet once daily.
Adults: If the patient takes one 15 mg tablet twice daily and a dose is missed, take the tablet as soon as possible. Do not take more than two 15 mg tablets in one day. If the patient forgot to take a dose, they may take two 15 mg tablets at the same time to achieve a total of two tablets (30 mg) taken within one day. The next day, continue taking one 15 mg tablet twice daily.

Taking more than the recommended dose of Bevimlar
If a patient has taken more than the recommended dose of Bevimlar, contact the doctor immediately.
Taking too high a dose of Bevimlar increases the risk of bleeding.

Stopping Bevimlar
Do not stop taking Bevimlar without first consulting your doctor, as Bevimlar helps prevent serious illness.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
As with other medicines with a similar mechanism of action that reduce blood clot formation, Bevimlar may cause bleeding, which potentially could be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Signs of bleeding are not always obvious or visible.
You should contact your doctor immediately if you experience any of the following adverse reactions:

Signs of bleeding – bleeding into the brain or inside the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness and neck stiffness. This is a serious medical emergency. Seek immediate medical help!), prolonged or excessive bleeding, unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. Your doctor may decide that close monitoring of the patient or a change in treatment is necessary.
Signs of severe skin reactions – widespread, acute skin rash, formation of blisters or mucosal lesions, e.g. on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis), drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). The frequency of these adverse reactions is very rare (up to 1 in 10,000 people).
Signs of severe allergic reactions – swelling of the face, lips, oral cavity, tongue or throat; urticaria and breathing difficulties; sudden drop in blood pressure. The frequency of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock, may occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in 1 in 100 people).

General list of possible adverse reactions in adults, children and adolescents:
Common (may occur in 1 out of 10 people)

decrease in red blood cell count which may cause paleness of the skin and lead to weakness or shortness of breath,
gastrointestinal or intestinal bleeding, bleeding from the urinary or genital tract (including blood in urine and severe menstrual bleeding), nosebleeds, gum bleeding,
bleeding into the eye (including conjunctival hemorrhage),
bleeding into tissues or body cavities (hematoma, bruising),
presence of blood in sputum (hemoptysis) during coughing,
skin bleeding or subcutaneous bleeding,
postoperative bleeding,
oozing of blood or fluid from the surgical wound,
limb swelling,
limb pain,
kidney function disorders (may be observed in tests performed by a doctor),
fever,
stomach pain, indigestion, nausea or vomiting, constipation, diarrhea,
low blood pressure (symptoms may include dizziness or fainting upon standing),
general decrease in strength and energy (weakness, fatigue), headache, dizziness,
rash, itching of the skin,
increased activity of certain liver enzymes, which may be seen in blood test results.

Uncommon (may occur in 1 out of 100 people)

intracranial or cerebral hemorrhage (see bleeding signs above),
joint bleeding causing pain and swelling,
thrombocytopenia (low platelet count, blood cells involved in blood clotting),
allergic reactions, including allergic skin reactions,
liver function disorders (may be observed in tests performed by a doctor),
blood tests may show increased levels of bilirubin, increased activity of certain pancreatic or liver enzymes, or increased platelet count,
fainting,
malaise,
rapid heartbeat,
dryness of the mouth,
urticaria.

Rare (may occur in 1 out of 1,000 people)

muscle bleeding,
cholestasis (bile stasis), hepatitis including liver cell damage,
yellowing of the skin and eyes (jaundice),
local swelling,
accumulation of blood (hematoma) in the groin as a complication of cardiac catheterization when the catheter is inserted into an artery in the leg (pseudoaneurysm).

Very rare (may occur in 1 out of 10,000 people)

accumulation of eosinophils, a type of granulocyte white blood cells, causing inflammation in the lungs (eosinophilic pneumonia).

Frequency not known (frequency cannot be estimated from available data)

kidney failure following severe bleeding,
bleeding in the kidneys, sometimes with presence of blood in urine, leading to impaired kidney function (drug-induced nephropathy associated with anticoagulant medicines),
increased pressure in the muscles of arms and legs following bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Adverse reactions in children and adolescents
In general, adverse reactions observed in children and adolescents treated with rivaroxaban were similar in type to those observed in adults and were mainly mild to moderate in severity.
Adverse reactions observed more frequently in children and adolescents:
Very common (may occur in more than 1 out of 10 people)

headache,
fever,
nosebleeds,
vomiting.

Common (may occur in 1 out of 10 people)

rapid heartbeat,
blood tests may show increased bilirubin levels (a bile pigment),
thrombocytopenia (low platelet count, platelets being cells that help blood to clot),
excessive menstrual bleeding.

Uncommon (may occur in 1 out of 100 people)

blood tests may show increased levels of a subcategory of bilirubin (direct bilirubin, a bile pigment).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Bevimlar

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard box
after: EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply to this medicine.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Bevimlar contains
The active substance is rivaroxaban.
Each coated tablet contains 15 mg or 20 mg of rivaroxaban.
The other ingredients are:

Tablet core: microcrystalline cellulose, lactose monohydrate, povidone K-30, corn starch, crospovidone type B, sodium lauryl sulfate, magnesium stearate. See section 2 "Bevimlar contains lactose".
Coating: hypromellose 2910, titanium dioxide (E171), macrogol 4000, iron oxide red (E 172).

What Bevimlar looks like and contents of the pack
The 15 mg coated tablets are red, round, biconvex, approximately 6 mm in size. Available in blisters containing 14, 28, 42 or 100 tablets in cardboard packaging.
The 20 mg coated tablets are brownish-red, round, biconvex, approximately 7 mm in size. Available in blisters containing 14, 28, 42 or 100 tablets in cardboard packaging.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warszawa
Poland
Tel. +48 22 737 79 20

Manufacturer / Importer:
STADA Arzneimittel AG
Stadastrasse 2-18,
61118 Bad Vilbel,
Germany
Laboratorios Liconsa S.A.
Avenida Miralcampo 7
Polígono Industrial Miralcampo
ES-19200 Guadalajara
Spain

This medicinal product is authorised in the European Economic Area under the following names:
Sweden: Bevimlar
Czech Republic: Bevimlar
Hungary: Bevimlar
Poland: Bevimlar
Slovakia: Bevimlar